NCT02159690

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kenneth Pienta, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the pathologic effects of the combination of enzalutamide, abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to prostatectomy in men with localized prostate cancer. Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is a 5-alpha-reductase inhibitor which blocks conversion of testosterone to dihydrotestosterone. Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to GnRH receptors on the pituitary gland thus suppressing testosterone release from the testes. Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate, dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable pathologic changes after 12 weeks of therapy.

Conditions

• Prostate Cancer
• Localized Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	160mg
DRUG	Abiraterone acetate	1000mg
DRUG	Prednisone	5mg twice daily (to blunt mineralocorticoid side effects from abiraterone)
DRUG	Dutasteride	0.5mg
DRUG	Degarelix	240mg SC loading dose on day 1, then three 80mg SC injections every 4 weeks thereafter

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-06-10
• Last updated: 2015-01-26

Locations

1 site across 1 country: United States